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Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01302886
Collaborator
(none)
41
Enrollment
13
Locations
1
Arm
30.1
Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: BHQ880

Drug: BHQ880

Outcome Measures

Primary Outcome Measures

  1. Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A [at 6 month]

Secondary Outcome Measures

  1. Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values [From start of study until disease progression]

  2. Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma [Throughout the study until disease progression]

  3. Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers [Throughout the study until disease progression]

  4. Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT [6 months and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma

  2. BMPC ≥ 10% and serum M-protein level ≥ 3 g/dL, OR

  3. BMPC ≥ 10%, serum M-protein level < 3 g/dL, and an abnormal free light chain ratio of < 0.125 or > 8.0

  4. No previous or current anti-myeloma therapies

  5. Patients ≥ 18 years of age

  6. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1

Exclusion Criteria:

  1. Previous treatment with IV bisphosphonates (i.e., pamidronate or zoledronic acid

  2. Another primary malignant disease that requires systemic treatment

  3. Concomitant Paget's disease of bone, uncorrected hyperparathyroidism, or uncontrolled thyroid disease

  4. Clinically significant uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)

  5. Treatment with an investigational product within 28 days before the first dose of study treatment

  6. Pregnant or nursing (lactating) women

  7. Women of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville Arkansas United States 72703
2 H. Lee Moffitt Cancer Center & Research Institute SC - 3 Tampa Florida United States 33612
3 Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) Atlanta Georgia United States 30322
4 Indiana University Indiana Univ Indianapolis Indiana United States 46202
5 Dana Farber Cancer Institute DFCI (2) Boston Massachusetts United States 02115
6 Washington University School of Medicine Dept. of WUSTL Saint Louis Missouri United States 63110
7 Hackensack University Medical Center Multiple Myeloma Division Hackensack New Jersey United States 07601
8 Mount Sinai School of Medicine Mt Sinai New York New York United States 10029
9 Duke University Medical Center Duke SC Durham North Carolina United States 27710
10 Fred Hutchinson Cancer Research Center Fred Hutchinson Seattle Washington United States 98109
11 Novartis Investigative Site LILLE Cedex France 59037
12 Novartis Investigative Site Heidelberg Germany 69120
13 Novartis Investigative Site Würzburg Germany 97080

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01302886
Other Study ID Numbers:
  • CBHQ880A2204
  • 2010-022029-13
First Posted:
Feb 24, 2011
Last Update Posted:
Dec 17, 2020
Last Verified:
Feb 1, 2017
Keywords provided by Novartis Pharmaceuticals
High risk Smoldering multiple myeloma,
BHQ880,
MM
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma

Study Results

No Results Posted as of Dec 17, 2020